Department of Internal Medicine, Ain Shams University, Faculty of Medicine, Cairo, Egypt.
Department of Internal Medicine, Tanta University, Tanta, Egypt.
Infect Disord Drug Targets. 2020;20(3):389-395. doi: 10.2174/1871526519666181218104600.
BACKGROUND & AIMS: Treatment plan of chronic HCV infection has dramatically improved after the introduction of different groups of Direct-Acting Antiviral (DAA) drugs. These drugs have been found to be safe and effective. Sofosbuvir (SOF) plus simeprevir (SMV) regimen has been shown to be tolerable and effective in treatment of patients with HCV genotype 1. The aim of the study was to evaluate the safety and the efficacy of combined sofosbuvir plus simeprevir treatment in genotype 4 chronic HCV patients.
This open-label multicenter prospective study was carried out on 381 Egyptian patients with chronic hepatitis C virus- infection. Treatment experienced and treatment-naive patients were included. Subjects administrated a regimen of sofosbuvir (400 mg/ day) plus semiprevir (150 mg /day) for twelve weeks. Sustained Virological Response (SVR) was confirmed by undetectable HCV RNA by quantitative PCR 3 months after the end of the treatment.
97.6% (372 /381) of patients had SVR. None of the studied clinical and demographic characteristics were associated with the SVR status. However, patients who failed to achieve SVR showed low albumin level and high total leucocyte. The most common side effects of the studied regimen were headache, fatigue, itching, photosensitivity, and cough.
Twelve weeks' regimen of sofosbuvir plus simeprevir was considered to be safe and tolerable in the treatment of HCV genotype 4; also it was associated with high SVR (97.6%).
直接作用抗病毒药物（DAA）的问世显著改善了慢性 HCV 感染的治疗方案。这些药物已被证明是安全有效的。索非布韦（SOF）联合simeprevir（SMV）方案已被证明在治疗 HCV 基因型 1 患者时具有良好的耐受性和疗效。本研究旨在评估 SOF 联合 SMV 治疗方案在 HCV 基因型 4 慢性患者中的安全性和疗效。
这是一项开放性、多中心、前瞻性研究，纳入了 381 例埃及慢性 HCV 感染患者。包括治疗经验和治疗初治患者。给予 SOF（400mg/天）加 SMV（150mg/天）治疗 12 周。治疗结束后 3 个月，通过定量 PCR 检测到不可检测的 HCV RNA 来确认持续病毒学应答（SVR）。
97.6%（372/381）的患者达到 SVR。研究中未发现任何临床和人口统计学特征与 SVR 状态相关。然而，未能达到 SVR 的患者表现出低白蛋白水平和高总白细胞。该研究方案最常见的副作用是头痛、疲劳、瘙痒、光敏感和咳嗽。
SOF 联合 SMV 治疗方案在 HCV 基因型 4 患者中是安全且耐受的，12 周的疗程与高 SVR（97.6%）相关。
